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February 29, 2012
Bias in Industry-Funded Trials in Rheumatoid Arthritis?
Posted by Derek
The title of this one says it all: "Association of industry funding with the outcome and quality of randomized controlled trials of drug therapy for rheumatoid arthritis". Any number of critics of the drug business will tell you what that association is: we publish the good stuff and bury the bad news, right?
Well, not so much in arthritis, apparently. The authors identified 103 recent clinical trials in the area, over half of them industry-funded. But when it came to outcomes, things were pretty much the same. Trials from the three largest classes of funding (industry, nonprofit, and "unspecified") all tended to strongly favor the tested drug, although the small number (six) of mixed-funding trials ended up with two favoring and four against. The industry-run trials tended to have more subjects, while the nonprofit ones tended to run longer. The industrial trials also tended to have a more complete description of their intent-to-treat and workflow. As you'd figure, the industrial trials tended to be on newer agents, while the others tended to investigate different combinations or treatment regimens with older ones. But the take-home is this:
No association between funding source and the study outcome was found after adjustment for the type of study drug used, number of study center, study phase, number of study subject, or journal impact factor. . .
. . .Though preponderance of data in medical literature shows that industry funding leads to higher chances of pro-industry results and conclusions, we did not find any association between the funding source and the study outcome of "published" (randomized clinical trials) of RA drug therapies.
The one worrying thing they did find was a trend towards publication bias - the industry-sponsored studies showed up less often in the literature. The authors speculate as to whether these were trials with less favorable outcomes, but didn't have enough data to say one way or another. . .
Comments (5)
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1. anon on February 29, 2012 8:51 AM writes...
Duh,
isn't the whole point of running the very expensive clinical trials to prove the efficacy and safety of the drug candidate in order to provide patients with a clinical benefit. Since the someone is putting up the money for a trial, and a lot of it, a good basis for the trial must already exist. Industry or any other sponsor isn't simply rolling the dice.
Finally, failure in a trial will halt a compounds progress quickly. That means many positive trial outcomes may precede a final negative result. That translates to many papers with positive outcomes leading to only a few paper with a negative trial outcomes.
So, one would expect nothing other than the trial results to be favoring positive outcomes.
Am I missing something?
Permalink to Comment2. PPedroso on February 29, 2012 9:14 AM writes...
@1
Yes,
you are missing that the funding origin does not influences that expected result and I think this was the aim of the work.
Permalink to Comment3. MTK on February 29, 2012 9:38 AM writes...
Yeah, but who was the source of funding for this study of the effect of the source of funding?
Permalink to CommentJust kidding by the way. The manuscript cites a grant from the NIH's National Center for Research Resources which was eliminated late last year.
4. Rick Wobbe on February 29, 2012 11:59 AM writes...
Looks like evidence of scientific integrity, which would be refreshing.
If I'm not mistaken, prior reports concluded that results of industry-funded trials that were published as JOURNAL ARTICLES tended to be disproportionately positive compared to what could be found among the larger number of reports in sources like ClinicalTrials.gov. If I'm right, then this report is not inconsistent with the prior observations because they're looking at different datasets: non-literature-published trial results (RCTs, ClinicalTrials.gov, etc.) vs. literature-published results (NEJM, etc.).
Permalink to Comment5. Brad Evans on February 29, 2012 11:46 PM writes...
1) There is a worry that medical journals receive so much funding from drug ads that they are biased in what they are willing to publish. The story is that the Annals of Internal Medicine published an article critical of drug ads in 1992 and nearly went into administration because they lost drug ads and their revenue.
2) Many organizations are establishing clinical guidelines based on evidence of drug efficacy published in the medical literature. The question is: Are some studies biased and therefore unreliable? Is there evidence that unfavorable studies have been deep sixed? (You can be biased by what you're told and what you're not told)
Thanks for your post.
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